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Behavioral Intervention

Menthol Regulation for Smoking Cessation

N/A

Recruiting

Research Sponsored by Medical University of South Carolina

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

adults (21+) who a) have been smoking at least 5 cigarettes daily for one year

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 1- week 7

Awards & highlights

Study Summary

This trial will study how menthol in cigarettes and e-cigarettes affects cigarette smoking & e-cigarette use, and assess possible impacts on health.

Who is the study for?

This trial is for adults over 21 who regularly smoke menthol cigarettes, use a specific brand most often, and have been smoking at least 5 cigarettes daily for one year. Participants must own a smartphone capable of receiving texts and internet access to complete diaries.Check my eligibility

What is being tested?

The study tests the impact of using non-menthol cigarettes vs. menthol ones, alongside menthol or tobacco-flavored e-cigarettes in a simulated regulatory environment. Over seven weeks, smokers' cigarette and e-cigarette usage patterns are monitored with incentives to abstain from smoking in the final week.See study design

What are the potential side effects?

While not explicitly listed, potential side effects may include typical nicotine withdrawal symptoms such as irritability, mood swings, cravings, difficulty concentrating, increased appetite leading to weight gain when switching from regular to non-menthol products.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been smoking 5 or more cigarettes daily for at least a year.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 1- week 7

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 1- week 7

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 1- week 7 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Changes in cigarettes per day

Secondary outcome measures

Ability to abstain from smoking

Fagerstrom Test for Nicotine Dependence

Trial Design

4Treatment groups

Experimental Treatment

Group I: Non-menthol Spectrum Cigarettes and Tobacco E-cigarettesExperimental Treatment2 Interventions

Ppts will be randomly assigned to receive the non-menthol spectrum cigarettes and Njoy Ace tobacco e-cigarettes. Will be used for the duration of the study (8 weeks) starting at the second visit.

Group II: Non-menthol Spectrum Cigarettes and Menthol E-cigarettesExperimental Treatment2 Interventions

Ppts will be randomly assigned to receive the non-menthol spectrum cigarettes and Njoy Ace menthol e-cigarettes. Will be used for the duration of the study (8 weeks) starting at the second visit.

Group III: Menthol Spectrum Cigarettes and Tobacco E-cigarettesExperimental Treatment2 Interventions

Ppts will be randomly assigned to receive the menthol spectrum cigarettes and Njoy Ace tobacco e-cigarettes. Will be used for the duration of the study (8 weeks) starting at the second visit.

Group IV: Menthol Spectrum Cigarettes and Menthol E-cigarettesExperimental Treatment2 Interventions

Ppts will be randomly assigned to receive the menthol spectrum cigarettes and Njoy Ace menthol e-cigarettes. Will be used for the duration of the study (8 weeks) starting at the second visit.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institutes of Health (NIH)NIH

2,701 Previous Clinical Trials

7,506,610 Total Patients Enrolled

University of MinnesotaOTHER

1,381 Previous Clinical Trials

1,588,735 Total Patients Enrolled

National Institute on Drug Abuse (NIDA)NIH

2,470 Previous Clinical Trials

2,619,491 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there vacant positions for participants in this experiment?

"According to official documentation on clinicaltrials.gov, this trial is still accepting participants after its initial posting date of October 23rd 2023 and most recent update was November 21st 2023."

Answered by AI

How many individuals are enrolled in the current clinical trial?

"Affirmative. Clinicaltrials.gov displays that this clinical study, which was uploaded on October 23rd 2023, is presently recruiting subjects. This research requires 240 individuals from 1 site to be enrolled."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Impact of Cigarette and E-cigarette Menthol Regulation on Current Smokers of Menthol Cigarettes

Tracy Smith 2023. "Impact of Cigarette and E-cigarette Menthol Regulation on Current Smokers of Menthol Cigarettes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05896033.